Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 9:46 AM
Study NCT ID:
NCT01065935
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2010-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'dispFirstSubmitDate': '2018-01-24', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2010-02-05', 'dispFirstSubmitQcDate': '2018-01-31', 'studyFirstSubmitQcDate': '2010-02-08', 'dispFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients', 'timeFrame': '180 days after randomization'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with FEV1 >80% of pre-infection baseline value', 'timeFrame': '90 and 180 days after randomization'}, {'measure': 'RSV symptoms as measured by mean cumulative daily total symptom score', 'timeFrame': '14 days after randomization'}, {'measure': 'Viral load as measured by viral area under the curve (AUC)', 'timeFrame': '6 days after randomization'}, {'measure': 'All cause mortality', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ALN-RSV01', 'RSV', 'Respiratory Syncytial Virus'], 'conditions': ['Respiratory Syncytial Virus Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single or bilateral lung transplant recipients\n* Confirmed RSV infection\n* Greater than 90 days post current lung transplant\n* Rejection free for a minimum of 30 days\n\nExclusion Criteria:\n\n* Known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis\n* Bronchiolitis obliterans syndrome (BOS) Grade 3 or any BOS with FEV1 that has not been stable for at least 3 months\n* Use of alemtuzumab within 9 months prior to screening, anti-thymocyte globulin (ATG) within 90 days of screening or prednisone or equivalent as maintenance therapy\n* Active treatment for acute graft rejection'}, 'identificationModule': {'nctId': 'NCT01065935', 'briefTitle': 'Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)', 'orgStudyIdInfo': {'id': 'ALN-RSV01-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ALN-RSV01', 'interventionNames': ['Drug: ALN-RSV01']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'ALN-RSV01', 'type': 'DRUG', 'description': 'Administered by nebulization once daily for 5 days', 'armGroupLabels': ['ALN-RSV01']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Administered by nebulization once daily for 5 days', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80202', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60153', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical 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'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Martin Zamora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Alan Glanville, MB BS MD Syd, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Vincents Hospital NSW W Australia'}, {'name': 'Jens T Gottlieb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alnylam Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}